FDA.reportPublic FDA data

COOLA Classic Liplux Lip Balm SPF 30 Original

Manufacturer
COOLA, LLC
Effective date
2024-05-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:12:57

Label at a glance#

ProductCOOLA Classic Liplux Lip Balm SPF 30 Original
Active ingredientOCTISALATE, AVOBENZONE, OCTOCRYLENE
Label structure10 sections

Indications and uses

Helps prevent sunburn If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure & again after 80 minutes of swimming or sweating. Apply at least every 2 hours. Sun Protection Measures - To decrease your risk of cancer and early skin aging, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. to 2 p.m. and wear long-sleeved shirts, pant...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Avobenzone – 2.9%
Octisalate – 4.9%
Octocrylene – 7.6%

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

WARNINGS SECTION

  • For external use only.
  • Do not use on damaged or broken skin.
  • When using this product keep out of eyes.
  • Stop use and ask doctor if skin rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure & again after 80 minutes of swimming or sweating.
  • Apply at least every 2 hours.
  • Sun Protection Measures - To decrease your risk of cancer and early skin aging, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. to 2 p.m. and wear long-sleeved shirts, pants, hats, and sunglasses.

INACTIVE INGREDIENT SECTION

Cocos Nucifera (Coconut) Oil (ORGANIC), Helianthus Annuus (Sunflower) Seed Oil (ORGANIC), Copernicia Cerifera (Carnauba) Wax (ORGANIC), Simmondsia Chinensis (Jojoba) Seed Oil (ORGANIC), Butyloctyl Salicylate, Euphorbia Cerifera (Candelilla) Wax, Theobroma Grandiflorum Seed Butter (ORGANIC), Ricinus Communis (Castor) Seed Oil (ORGANIC), Astrocaryum Vulgare Kernel Oil (ORGANIC), Behenyl Behenate, Polyhydroxystearic Acid, Bisabolol (ORGANIC), Rosmarinus Officinalis (Rosemary) Leaf Extract (ORGANIC), Rosa Canina Fruit Extract (ORGANIC), Rubus Idaeus (Raspberry) Seed Oil (ORGANIC), Caprylic/Capric Triglyceride, Linoleic Acid, Phytosterols, Phospholipids, Persea Gratissima (Avocado) Oil (ORGANIC), Tetrahexyldecyl Ascorbate, Carthamus Tinctorius (Safflower) Seed Oil, Aloe Barbadensis Leaf Extract, Stevia Rebaudiana Extract, Flavor

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun. May stain fabrics.

OTC - QUESTIONS SECTION

Call 760-940-2125

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79753-067-01COOLA Classic Liplux Lip Balm SPF 30 Original1 in 1 CARTONSTICK13
79753-067-01COOLA Classic Liplux Lip Balm SPF 30 Original4.2 g in 1 TUBESTICK4.23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79753-067COOLA CLASSIC LIPLUX LIP BALM SPF 30 ORIGINAL (AVOBENZONE, OCTISALATE, OCTOCRYLENE) STICK [COOLA, LLC]3Current NDC, Legacy NDC, 2 package rows20240524_eeb420f0-c92f-0d96-e053-2a95a90afe36.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79753-06779753-067-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
LINOLEIC ACID9KJL21T0QJIACT
ALOE VERA LEAFZY81Z83H0XIACT
BEHENYL BEHENATEK8NU647RJ0IACT
CARNAUBA WAXR12CBM0EIZIACT
CANDELILLA WAXWL0328HX19IACT
CASTOR OILD5340Y2I9GIACT
LEVOMENOL24WE03BX2TIACT
AVOCADO OIL6VNO72PFC1IACT
SUNFLOWER OIL3W1JG795YIIACT
THEOBROMA GRANDIFLORUM SEED BUTTERI711F13FXMIACT
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
OCTOCRYLENE5A68WGF6WMACTIB
COCONUT OILQ9L0O73W7LIACT
JOJOBA OIL724GKU717MIACT
ASTROCARYUM VULGARE KERNEL OIL1IQY04O559IACT
RASPBERRY SEED OIL9S8867952AIACT
SOY STEROLPL360EPO9JIACT
ROSEMARYIJ67X351P9IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
SAFFLOWER OIL65UEH262ISIACT
STEVIA REBAUDIUNA LEAF6TC6NN0876IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
ROSA CANINA FRUIT3TNW8D08V3IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COOLA Classic Liplux Lip Balm SPF 30 OriginalAVOBENZONE, OCTISALATE, OCTOCRYLENECOOLA, LLCeeb420f0-c92f-0d96-e053-2a95a90afe362024-05-22WarningsExact identifier
ndc (package): 79753-067-01
ndc (product): 79753-067
ndc11 (package): 79753006701
spl id: 190de8e0-4ba5-fb2f-e063-6294a90a9a2f
spl set id: eeb420f0-c92f-0d96-e053-2a95a90afe36

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.